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Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene


Phase 4
N/A
N/A
Open (Enrolling by invite only)
Female
Breast Cancer

Thank you

Trial Information

Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene


1. Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months
with Letrozole in postmenopausal women with hormone receptor positive breast cancer who
complete 5 years of Toremifene

2. Secondary purpose

- To evaluate follows after taking 36 months with Letrozole in postmenopausal women
with hormone receptor positive breast cancer who complete 5 years of Toremifene.

1. Disease Free Survival rate(DFS)-12 months, 24 months

2. Distant disease free survival rate(DDFS), Overall Survival(OS)

- 12 months, 24 months, 36 months c. safety

- Change of lipid profiles

- Mortality and morbidity due to Cardiovascular disease

- Incidence of Fracture

- Change of Bone density

- Common toxic effect


Inclusion Criteria:



1. Patients have undergone surgery of the breast cancer and proven histologically to be
invasive breast cancer.

2. Removed the breast cancer histologically or cytologically

3. No evidence of breast cancer in controlateral breast

4. No evidence of metastasis

5. Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5
Years of Toremifene in 30 months

6. Postmenopausal state was defined the following conditions, at least one of a, b

1. Serum FSH ≥ 30 mIU/mL

2. Amenorrhea ≥ 1 year

7. Estrogen receptor(+) or Progesterone receptor(+)

8. No Evidence of Recurrence

Exclusion Criteria:

1. Patient with hormone receptor negative

2. Patients with malignancies

3. Patients with other aromatase inhibitor and chemotherapy

4. Patients with Other hormone therapy and Hormonal replacement therapy

5. Patients with Hormone replacement therapy during taking Toremifene

6. Estimated life expectancy of <12 months

7. WBC<3,000/mm3 or Platelet count<100,000/mm3

8. AST and/or ALT ≥2xUNL

9. Alkaline phosphatase ≥2xUNL

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival rate

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Sei-Hyun Ahn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Asan medical center, South Korea

Authority:

Korea: Food and Drug Administration

Study ID:

KBCSG007

NCT ID:

NCT01072318

Start Date:

January 2010

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • extended adjuvant hormonal therapy
  • letrozole
  • Toremifene
  • Breast Neoplasms

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